ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter recall: Labeling Error
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Why was ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter recalled?
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
A213373 and A216702
- Product
- ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Recalling firm
- ev3, Inc.
- Quantity
- 27 (25 US, 2 OUS)
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)